Reusable sinus dilation instrument and method of use

ABSTRACT

The invention is directed to a system and method for a less invasive surgical tool and operation to correct sinus disease called balloon sinuplasty. The reusable sinus dilation instrument has a guide seeker constructed from a sterilizable material with a bended terminal end offset from an attachment terminal end and a central grip intermediate of the terminal ends. The instrument also includes a removable handle capable of being attached to the attachment terminal end at a predetermined orientation relative to the bended terminal end of the guide seeker depending upon if the instrument is a frontal sinus guide seeker, a maxillary sinus guide seeker or a sphenoid sinus guide seeker. The bended terminal end of the guide seeker can be selectively angled so that the guide seeker is a frontal sinus guide seeker, a maxillary sinus guide seeker or a sphenoid sinus guide seeker.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. ProvisionalPatent Application No. 61/915,791, filed Dec. 13, 2013, which isincorporated herein by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable.

NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT

Not Applicable.

REFERENCE TO A SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTINGAPPENDIX

Not Applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to a reusable sinus dilation instrumentand method of use, and more particularly to a reusable sinus dilationinstrument having a guide seeker constructed from a sterilizablematerial with a bended terminal end offset from an attachment terminalend and a central grip intermediate of the terminal ends, and having aremovable handle capable of being attached to the attachment terminalend at a predetermined orientation relative to the bended terminal endof the guide seeker.

2. Description of the Related Art

Sinus disease often occurs because of blockage. The blockage trapsmucous in a warm, moist environment and can produce infection. Blockagealso allows pressure to build which can cause pain and pressure over thesinus cavities. Balloon sinuplasty is a newer less invasive operation tocorrect sinus disease. During the procedure, no mucosal tissue isremoved, rather the ostia or opening on the sinus is enlarged byinserting a balloon that is inflated. The opening then heals in the openposition. Balloon sinuplasty overcomes the infection, pain, and pressureby keeping the sinus ostia open.

Current medical-grade instruments used in balloon sinuplasty have a highcost because most of the parts are intended for one time only use. Thereare less expensive instruments, but those instruments have problems withbulk and awkward angles, which make these instruments very difficult touse and can cause more tissue trauma, which may lead to more scarringand revisions.

It is therefore desirable to provide an improved reusable sinus dilationinstrument and method of use.

It is further desirable to provide a reusable sinus dilation instrumentthat can be safely sterilized, has better angles for finding the sinus,and has less profile so as to cause less tissue trauma.

It is still further desirable to provide a reusable sinus dilationinstrument having a guide seeker and a disposable balloon capable ofbeing slipped over the guide seeker.

It is yet further desirable to provide a reusable sinus dilationinstrument having a guide seeker with a bended terminal end offset froman attachment terminal end and a central grip intermediate of theterminal ends.

It is still yet further desirable to provide a reusable sinus dilationinstrument having a removable handle capable of being attached to anattachment terminal end at a predetermined orientation relative to abended terminal end of a guide seeker of the instrument.

It is yet further desirable to provide a reusable sinus dilationinstrument where the angle of the terminal bend varies depending on thesinus being treated, e.g., about 45 degrees for frontal, about 95degrees for maxillary, and about 10 degrees for sphenoid sinus.

It is still yet further desirable to provide a reusable sinus dilationinstrument having a fiber optic cable in the center of the guide seeker.

It is still yet further desirable to provide a reusable sinus dilationinstrument made of sterilizable material, e.g. stainless steel.

It is still yet further desirable to provide a reusable sinus dilationinstrument having a removable handle capable of being attached to theinstrument using a luer taper fitting, a threaded attachment or otherattachment means.

Other advantages and features will be apparent from the followingdescription and from the claims.

SUMMARY OF THE INVENTION

In general, the invention relates to a reusable sinus dilationinstrument and method of use for less invasive balloon sinuplasty forcorrection of sinus disease. The instrument may be sterilized andreused, has better angles for finding the sinus and causes less tissuetrauma. The instrument includes a guide seeker having a bended terminalend offset from an attachment terminal end and a central gripintermediate of the terminal ends. The instrument also includes aremovable handle attachable to the attachment terminal end at apredetermined orientation relative to the bended terminal end of theguide seeker. The bended terminal end may be approximately 2.5 cmlength, and has an angle that varies depending on sinus beingtreated—approximately 45 degrees for frontal, approximately 95 degreesfor maxillary, and approximately 10 degrees for sphenoid sinus. Inaddition, a fiber optic cable may be placed in the center of the guideseeker. The guide seeker may be made of sterilizable material, e.g.stainless steel. The removable handle may be attached to the instrumentusing a luer taper fitting, a threaded attachment or other attachmentmeans.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of an example of a reusable sinus dilationinstrument having a frontal sinus guide seeker and a removable handleoriented generally coplanar with and parallel to a bended terminal endof the guide seeker in accordance with an illustrative embodiment of theinvention disclosed herein;

FIG. 2 is a side view of the instrument shown in FIG. 1;

FIG. 3 is an exploded view of the instrument shown in FIG. 2;

FIG. 4 is an exploded view of area 4 as shown in FIG. 2;

FIG. 5 is a side view of an example of a reusable sinus dilationinstrument having a disposable balloon capable of being slipped over abended terminal end of a guide seeker in accordance with an illustrativeembodiment of the invention disclosed herein;

FIG. 6 is a side view of another example of a reusable sinus dilationinstrument having a disposable balloon capable of being slipped over anattachment terminal end of a guide seeker in accordance with anillustrative embodiment of the invention disclosed herein;

FIG. 7 is a side view of the reusable sinus dilation instrument shown inFIGS. 5 and 6 with the disposable balloon seated over the guide seeker;

FIG. 8 is a side fragmentary view of an example of a maxillary sinusguide seeker in accordance with an illustrative embodiment of theinvention disclosed herein;

FIG. 9 is a side fragmentary view of the maxillary sinus guide seekershown in FIG. 8 with a disposable balloon seated on a bended terminalend;

FIG. 10 is a side fragmentary view of an example of a sphenoid sinusguide seeker in accordance with an illustrative embodiment of theinvention disclosed herein;

FIG. 11 is a side fragmentary view of the sphenoid sinus guide seekershown in FIG. 10 with a disposable balloon seated on a bended terminalend;

FIG. 12 is a side view of another example of a reusable sinus dilationinstrument having a removable handle attachable a frontal sinus guideseeker at a predetermined orientation in accordance with an illustrativeembodiment of the invention disclosed herein;

FIG. 13 is a side view of the reusable sinus dilation instrument shownin FIG. 12 with the removable handle attached to the guide seeker andoriented generally coplanar with and in an opposing parallel directionto a bended terminal end of the frontal sinus guide seeker; and

FIG. 14 is a perspective view of another example of a reusable sinusdilation instrument having a maxillary sinus guide seeker and aremovable handle disposed generally perpendicular to a bended terminalend of the guide seeker in accordance with an illustrative embodiment ofthe invention disclosed herein.

DETAILED DESCRIPTION OF THE INVENTION

The instruments and methods discussed herein are merely illustrative ofspecific manners in which to make and use this invention and are not tobe interpreted as limiting in scope.

While the invention has been described with a certain degree ofparticularity, it is to be noted that many modifications may be made inthe construction and the arrangement of its components without departingfrom the scope of the invention. It is understood that the invention isnot limited to the embodiments set forth herein for purposes ofexemplification.

The description of the invention is intended to be read in connectionwith the accompanying drawings, which are to be considered part of theentire written description of this invention. In the description,relative terms such as “front,” “rear,” “lower,” “upper,” “horizontal,”“vertical,” “above,” “below,” “up,” “down,” “top” and “bottom” as wellas derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly”etc.) should be construed to refer to the orientation as then describedor as shown in the drawings under discussion. These relative terms arefor convenience of description and do not require that the machine beconstructed or the method to be operated in a particular orientation.Terms, such as “connected,” “connecting,” “attached,” “attaching,”“join” and “joining” are used interchangeably and refer to one structureor surface being secure to another structure or surface or integrallyfabricated in one piece.

Referring to the figures of the drawings, wherein like numerals ofreference designate like elements throughout the several views, andinitially to FIGS. 1 through 7, a reusable sinus dilation instrument 10has a guide seeker 12 constructed from a sterilizable material, such asstainless steel. The guide seeker 12 includes a bended terminal end 14offset from an attachment terminal end 16 and a central grip 18intermediate of the terminal ends 14/16. The instrument 10 also includesa removable handle 20 capable of being attached to the attachmentterminal end 16 at a predetermined orientation relative to the bendedterminal end 14 of the guide seeker 12.

As exemplified in FIGS. 1 through 3 and 5 through 7, the guide seeker 12is a frontal sinus guide seeker 12 with the removable handle 20 orientedgenerally coplanar with and parallel to the bended terminal end 14 ofthe guide seeker 12. The bended terminal end 14 of the frontal sinusguide seeker 12 may have an angle A of about 45 degrees with a longgentle curve of approximately 2.5 cm in length L1. A tip 22 of the curveof the bended terminal end 14 may be approximately 1 mm diameter andprogressively enlarge to about 2 mm in diameter over a length L2 ofabout 8 cm. The length L3 of the central grip 18 of the guide seeker 12continues the diameter of approximately 2 mm to the attachment terminalend 16 of the guide seeker 12.

The removable handle 20 of the instrument 10 is capable of beingattached to the attachment terminal end 16 at a predeterminedorientation relative to the bended terminal end 14 of the guide seeker12. The handle 20 of the instrument 10 may increase in diameter to about5 mm and be about 2 cm in length L4. Similarly to the guide seeker 12,the handle 20 may be constructed of a sterilizable material, such asstainless steel. As depicted in the figures, namely FIG. 4, the handle20 is coupled to the attachment terminal end 16 of the guide seeker 12using a threaded attachment mechanism 24; however, the invention is notso limited as the handle 20 can be attached to the instrument 10 using aluer taper fitting or other suitable attachment means. The handle 20 mayinclude a wing 26 attached to and protrude away from a body 28 of thehandle 20. The wing 26 may be about 2 mm thick, about 3.5 cm long andabout 2 cm wide, resulting in the instrument 10 having a length of about23 cm from the tip 22 of the bended terminal end 14 of the guide seeker12. As illustrated in FIGS. 1 through 3 and 5 through 7, the handle 20is oriented generally coplanar with and parallel to the bended terminalend 14 of the front sinus guide seeker 12. Alternatively as illustratedin FIGS. 12 and 13, the handle 20 may be selectively attached to theattachment terminal end 16 of the guide seeker 12 such that the wing 26of the handle 20 projects in a direction opposite of the curve of thebended terminal end 14 of the guide seeker 12.

As can be seen in FIGS. 5 through 7, a disposable balloon 30 may beslipped directly over the guide seeker 12 and does not have to beremoved or advanced, although the balloon 30 could be advanced ifneeded. The balloon 30 may be about 6 mm in diameter and about 18 mmlong. The balloon 30 is positioned along the length L1 of the gentlecurve of the bended terminal end 14, with a leading end 32 positionedabout 1 mm from the tip 22 of the bending terminal end 14 and a terminalend 34 positioned along length L2 of the central grip 18 of the guideseeker 12. As illustrated in FIG. 5, the balloon 30 is slipped over thebended terminal end 14 of the guide seeker 12 while in FIG. 6 theballoon 30 is slipped over the attachment terminal end 16 of the guideseeker 12. Once the balloon 30 is seated over the guide seeker 12 asdepicted in FIG. 7, a suitable air supply (not shown) may be fluidlycoupled to an attachment mechanism 36 of the disposable balloon 30.

Referring now to FIGS. 8, 9 and 14, the reusable sinus dilationinstrument 10 includes a maxillary sinus guide seeker 12 having thebended terminal end 14 with a rounded approximately 95 degree angle A.Similarly to the front sinus guide seeker discussed above, the bendedterminal end 14 of the maxillary sinus seeker 12 may be approximately 8mm in length L1 from the central grip 18. The diameter of the bendedterminal end 14 is about 1 mm and progressively increases to about 2 mmin diameter for a length of about 8 cm along the central grip 18 of theguide seeker 12. The handle 20 is coupled to the attachment terminal end16 of the guide seeker 12 and increases the diameter to about 5 mm andis about 2 cm in length. The wing 26 of the handle 30 may be about 2 mmin thickness, about 3.5 cm long, about 2 cm wide and about 23 cm fromthe tip 22 of the bended terminal end 14 of the guide seeker 12. Asshown in FIG. 14, the handle 20 is disposed generally perpendicular tothe bended terminal end 14 of the guide seeker 12. Although the handle20 is exemplified as having a single wing 26 attached to and projectingfrom the body 28 of the handle 20, the handle 20 can include two (2)opposing wings 26 affixed to and protruding away from the body 28, andin such an embodiment, each of the wings 26 would be oriented generallyperpendicular to the angle A of the bended terminal end 14 of the guideseeker 12.

Referring now to FIGS. 10 and 11, the reusable sinus dilation instrument10 includes a sphenoid sinus guide seeker 12 having the bended terminalend 14 with a gentle curve having an approximately 10 degree angle A.The gentle curve may measure about 1 cm long and about 2 mm at the tip22 of the bended terminal end 14 of the guide seeker 12. The diametercan be about 2 mm for a length of about 8 cm, and then increase to about5 mm in diameter for about 2 cm in length. The wing 26 and the handle 20of the sphenoid sinus guide seeker 20 may be configured and orientedsimilarly to the frontal sinus guild seeker 12, namely, the handle 20 isoriented generally coplanar with the bended terminal end 14 of the frontsinus guide seeker 12. In addition, the handle 20 may be selectivelypositioned such that the wing 26 of the handle 20 is parallel to thebended terminal end 14 of the front sinus guide seeker 12 or such thatthe wing 26 of the handle 20 projects in a direction opposite of thecurve of the bended terminal end 14 of the guide seeker 12.

Additionally, the handle 20 of the reusable sinus dilation instrument 10may be specifically constructed for left or right sinus cavityprocedures, and could be made with one wing 26 or with two (2) opposingwings 26. The balloon 30 may also have a locking mechanism (not shown)onto the handle 20, along with smaller wings 26 to allow advancement ifneeded.

The reusable sinus dilation instrument 10 may include a fiber opticelement (not shown) embedded within a center channel (not shown) of theguide seeker 12 allowing the practitioner to confirm positioning andplacement of the balloon 20 in the sinus cavity using transdermalillumination. With embedded fiber optics, the diameter of the tip 22 atthe bended terminal end 14 of the guide seeker 12 increase to about 2mm.

Whereas, the instruments and methods have been described in relation tothe drawings, it should be understood that other and furthermodifications, apart from those shown or suggested herein, may be madewithin the scope of this invention.

What is claimed is:
 1. A reusable sinus dilation instrument, comprising:a guide seeker constructed from a sterilizable material, said guideseeker comprising a bended terminal end offset from an attachmentterminal end, said guide seeker comprising a central grip intermediateof said terminal ends; a removable handle attachable to said attachmentterminal end at a predetermined orientation relative to said bendedterminal end of said guide seeker.
 2. The instrument of claim 1 whereinsaid handle is constructed of a sterilizable material.
 3. The instrumentof claim 2 wherein said sterilizable material of said guide seekerand/or said handle is stainless steel.
 4. The instrument of claim 1further comprising a disposable balloon capable of being slippeddirectly over said guide seeker.
 5. The instrument of claim 1 whereinsaid removable handle is about 5 mm in diameter and about 2 cm inlength.
 6. The instrument of claim 1 wherein said handle is coupled tosaid attachment terminal end of said guide seeker using an attachmentmeans selected from the group consisting of a threaded attachment or aluer taper fitting.
 7. The instrument of claim 1 wherein said handlefurther comprises at least one wing attached to and protruding away froma body of said handle.
 8. The instrument of claim 7 wherein said wing isabout 2 mm thick, about 3.5 cm long and about 2 cm wide.
 9. Theinstrument of claim 7 wherein said wing of said handle is orientedgenerally coplanar with and parallel to said bended terminal end of saidfront sinus guide seeker.
 10. The instrument of claim 9 wherein saidwing of said handle protrudes in a direction opposite of said bendedterminal end of said guide seeker.
 11. The instrument of claim 9 whereinsaid guide seeker is a frontal sinus guide seeker.
 12. The instrument ofclaim 11 wherein said bended terminal end of said frontal sinus guideseeker has an angle of about 45 degrees with a long gentle curve ofapproximately 2.5 cm in length.
 13. The instrument of claim 9 whereinsaid guide seeker is a sphenoid sinus guide seeker.
 14. The instrumentof claim 13 wherein said bended terminal end of said sphenoid guideseeker has a gentle curve with an approximately 10 degree angle.
 15. Theinstrument of claim 7 wherein said wing of said handle is orientedgenerally perpendicular to said bended terminal end of said guideseeker.
 16. The instrument of claim 15 wherein said guide seeker is amaxillary sinus guide seeker.
 17. The instrument of claim 16 whereinsaid bended terminal end has a rounded approximately 95 degree angle.18. The instrument of claim 16 wherein said handle further comprises two(2) opposing wings affixed to and protruding away from said handle, andeach of said wings oriented generally perpendicular to said angle ofsaid bended terminal end of said guide seeker.
 19. The instrument ofclaim 7 wherein said at least one wing further comprises a pair of wingsattached to and protruding away from opposing sides of said body of saidhandle.
 20. The instrument of claim 1 wherein a tip of said bendedterminal end is approximately 1 mm in diameter and progressivelyenlarges to about 2 mm in diameter over a length of about 8 cm.